Rodolfo Mattioli,
Cesare Gridelli,
Javier Castellanos,
Antonio Duque,
Alfredo Falcone,
Mauro Mansutti,
Pam Bacon, Sue Lawrinson,
Tomas Skacel,
J. Belon,
L. Estévez,
J. Mata,
A. Scanni,
Ana Casas
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ABSTRACT: AimIn several commonly used regimens, chemotherapy doses are split across different days of the cycle. We aimed to determine
the feasibility of growth factor support with once-per-cycle pegfilgrastim in this setting.
MethodsThis phase II study in breast cancer patients assessed the utility of a single 6 mg subcutaneous dose of pegfilgrastim administered
on day 9 of an intravenous (IV) “split” CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2 and 5-fluorouracil 600 mg/m2) chemotherapy regimen administered on days 1 and 8 and repeated every 28 days for 6 cycles.
ResultsFifty-eight patients were enrolled, with 49 completing the study. For the primary endpoint, 48 patients (83%) received ≥85%
of the relative dose intensity (RDI) of chemotherapy over all 6 cycles (95% confidence interval [CI], 71–91%). Across all
chemotherapy cycles, 41 patients (71%) received all scheduled cycles on time and most patients (n=49, 84%) received ≥85% of the planned dose of all chemotherapy agents in all cycles. In total, 295/319 cycles (92%) were
delivered on schedule and ≥85% of the planned dose of all chemotherapy agents were administered in 309/319 cycles (97%). Febrile
neutropenia was reported in only 2 patients (3%). There were no grade 4 adverse events related to pegfilgrastim.
DiscussionDay 9 pegfilgrastim administration was well tolerated and provided effective protection against neutropenia in patients receiving
IV CMF on days 1 and 8, allowing chemotherapy to be delivered on time and at the scheduled dose in most patients.
Clinical and Translational Oncology 04/2012; 11(12):842-848. · 1.33 Impact Factor
